Semilente

   
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Semilente


Drug - Semilente
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Insulin Zinc Susp Prompt Purified Pork
Multiple ingredients are in alphabetical order.

Strength - 100 UNITS/ML
The potency of the active ingredient(s), Insulin Zinc Susp Prompt Purified Pork. May repeat for multiple part products.

Applicant - NOVO NORDISK INC
The firm name holding legal responsibility for Semilente. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018382
The FDA assigned number to Semilente. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Semilente. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Semilente was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Semilente. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Semilente is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novo Nordisk Inc
The full name of the firm holding legal responsibility for the new application of Semilente.

Semilente